NCT05215457

Brief Summary

To enable emergency physicians to make well-informed triage and treatment decisions, accurate tools to evaluate the severity of diquat poisoning are needed. This study establishes severity indices for diquat poisoning (SIDPs) in assessing the risk of death for patients with acute diquat poisoning for triage purposes and 28-day mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

January 1, 2022

Last Update Submit

April 16, 2025

Conditions

Diquat Poisoning

Keywords

diquatpoisoningtriageprognosissurvival analysis

Outcome Measures

Primary Outcomes (2)

  • 28-day survival

    The primary outcome measure includes 28-day survival (survived or died).

    28 days from the index date

  • Time from exposure to death

    The primary outcome included time from exposure to death.

    28 days from the index date

Study Arms (2)

Development Set

The development set included 106 patients, comprising 67 survivors and 39 fatalities, with a case fatality rate of 36.8%; 56.6% were men. Data from the study center (teaching hospital affiliated to Nanjing Medical University) were used for model development.

External Validation Set

The external validation set included 98 patients, comprised of 69 survivors and 29 fatalities, with a case fatality rate of 29.6%; 61.2% were women. Data from other hospitals (except study center) were used for external validation.

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute diquat poisoning

You may qualify if:

  • history of oral exposure to diquat solution reported by patient or proxy;
  • a specimen for the diquat plasma concentration collected immediately upon admission;
  • documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.
  • Patients were excluded if:
  • they had ingested other toxicants in addition to diquat;
  • diquat was not detected in biological samples;
  • patients with over half of incomplete information;
  • patients with an exposure time (time from exposure to presentation at ED) longer than 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (13)

  • Cao ZX, Zhao Y, Gao J, Feng SY, Wu CP, Zhai YZ, Zhang M, Nie S, Li Y. Comparison of severity index and plasma paraquat concentration for predicting survival after paraquat poisoning: A meta-analysis. Medicine (Baltimore). 2020 Feb;99(6):e19063. doi: 10.1097/MD.0000000000019063.

    PMID: 32028427BACKGROUND

  • Kim DS, Kang C, Kim DH, Kim SC, Lee SH, Jeong JH, Kang TS, Jung SM, Lee SB, Lee KW, Kim RB. External validation of the prognostic index in acute paraquat poisoning. Hum Exp Toxicol. 2016 Apr;35(4):366-70. doi: 10.1177/0960327115586821. Epub 2015 May 13.

    PMID: 25977258BACKGROUND

  • Chen CK, Chen YC, Megarbane B, Yeh YT, Chaou CH, Chang CH, Lin CC. The acute paraquat poisoning mortality (APPM) score to predict the risk of death in paraquat-poisoned patients. Clin Toxicol (Phila). 2022 Apr;60(4):446-450. doi: 10.1080/15563650.2021.1979234. Epub 2021 Sep 20.

    PMID: 34543159BACKGROUND

  • Xu S, Hu H, Jiang Z, Tang S, Zhou Y, Sheng J, Chen J, Cao Y. APACHE score, Severity Index of Paraquat Poisoning, and serum lactic acid concentration in the prognosis of paraquat poisoning of Chinese Patients. Pediatr Emerg Care. 2015 Feb;31(2):117-21. doi: 10.1097/PEC.0000000000000351.

    PMID: 25654678BACKGROUND

  • Du Y, Mou Y. [Predictive value of 3 methods in severity evaluation and prognosis of acute paraquat poisoning]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2013 Jul;38(7):737-42. doi: 10.3969/j.issn.1672-7347.2013.07.014. Chinese.

    PMID: 23908083BACKGROUND

  • Xing J, Chu Z, Han D, Jiang X, Zang X, Liu Y, Gao S, Sun L. Lethal diquat poisoning manifesting as central pontine myelinolysis and acute kidney injury: A case report and literature review. J Int Med Res. 2020 Jul;48(7):300060520943824. doi: 10.1177/0300060520943824.

    PMID: 32734801BACKGROUND

  • Magalhaes N, Carvalho F, Dinis-Oliveira RJ. Human and experimental toxicology of diquat poisoning: Toxicokinetics, mechanisms of toxicity, clinical features, and treatment. Hum Exp Toxicol. 2018 Nov;37(11):1131-1160. doi: 10.1177/0960327118765330. Epub 2018 Mar 23.

    PMID: 29569487BACKGROUND

  • Oreopoulos DG, McEvoy J. Diquat poisoning. Postgrad Med J. 1969 Sep;45(527):635-7. doi: 10.1136/pgmj.45.527.635. No abstract available.

    PMID: 5809561BACKGROUND

  • Cai XL, Teng F, Yu X, Liu LL, Li GQ. [Four cases of acute diquat poisoning with prominent epileptoid seizure and literature review]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2021 May 20;39(5):359-362. doi: 10.3760/cma.j.cn121094-20200224-00078. Chinese.

    PMID: 34074081BACKGROUND

  • Yuan G, Li R, Zhao Q, Kong X, Wang Y, Wang X, Guo R. Simultaneous determination of paraquat and diquat in human plasma by HPLC-DAD: Its application in acute poisoning patients induced by these two herbicides. J Clin Lab Anal. 2021 Mar;35(3):e23669. doi: 10.1002/jcla.23669. Epub 2020 Dec 9.

    PMID: 33296104BACKGROUND

  • Jones GM, Vale JA. Mechanisms of toxicity, clinical features, and management of diquat poisoning: a review. J Toxicol Clin Toxicol. 2000;38(2):123-8. doi: 10.1081/clt-100100926.

    PMID: 10778908BACKGROUND

  • Saeed SA, Wilks MF, Coupe M. Acute diquat poisoning with intracerebral bleeding. Postgrad Med J. 2001 May;77(907):329-32. doi: 10.1136/pmj.77.907.329.

    PMID: 11320278BACKGROUND

  • Huang Y, Zhang R, Meng M, Chen D, Deng Y. High-dose diquat poisoning: a case report. J Int Med Res. 2021 Jun;49(6):3000605211026117. doi: 10.1177/03000605211026117.

    PMID: 34182818BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma

MeSH Terms

Conditions

Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Jingsong Zhang, MD, PhD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 1, 2022

First Posted

January 31, 2022

Study Start

February 1, 2022

Primary Completion

July 31, 2023

Study Completion

January 13, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)